Swedish Orphan Biovitrum

Sobi® (STO: SOBI) and Enable Injections, Inc. (Enable) today announced an international development and distribution agreement across Sobi territories for the enFuse® Injector, for the subcutaneous delivery of Aspaveli® (pegcetacoplan).  

The enFuse Injector, to be produced by Enable and distributed by Sobi, is designed to streamline and improve patients’ self-administration experience with minimal disruption to their daily lives via the use of enFuse technology. This allows wearable, hidden needle drug delivery through a simple injection under the skin.

"We are dedicated to advancing innovative solutions for the treatment of rare diseases, and this agreement with Enable Injections marks an important step in fulfilling that commitment," said

Lydia Abad-Franch, MD, Head of R&D, Medical Affairs, and Chief Medical Officer at Sobi. “We believe the agreement with Enable will potentially expand patient choice, enhance comfort and support adherence, with the ultimate aim of better health outcomes. By continually improving the patient experience, we are working to make a meaningful difference in the lives of those we serve."

“The future availability of Aspaveli with Enable Injections’ enFuse technology, could offer more patients the opportunity to access a simplified treatment experience that allows for greater confidence and mobility,” said Michael D. Hooven, Enable Injections' Chairman and CEO. “Enable was founded on the goal of redefining drug delivery for the benefit of patients, and our partnership with Sobi is helping us achieve that. Following regulatory approvals, enFuse will potentially be the first subcutaneous drug delivery device of its kind outside of the U.S. and we look forward to improving the treatment experience of even more patients as we establish additional enFuse partnerships.”

About Aspaveli®/EMPAVELI®  
Aspaveli®/EMPAVELI® (pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. It is approved for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) in the United States, European Union, and other countries globally. The therapy is also under investigation for several other rare diseases across haematology and nephrology. 

About the Sobi and Apellis collaboration

Sobi and Apellis have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialisation rights for systemic pegcetacoplan, and Apellis has exclusive U.S. commercialisation rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.

About Enable Injections

Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of enFuse®. enFuse is an innovative wearable drug delivery platform that is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information about the Company’s approved enFuse combination production, visit https://enableinjections.com/our-products.

About Sobi®

Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia, and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

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